Safety of the Herpes Zoster Subunit Vaccine in Lupus
Recruiting
Phase 4
Interventional Study
Systemic Lupus Erythematosus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 90
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 224 (estimated)
- Sponsor
- NYU Langone Health · Other
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About This Trial
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to t…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Provision of informed consent prior to any study specific procedures
2. Female or male ≥18 years of age at the time of signing the informed consent
3. Meet the 2019 EULAR/ACR Classification Criteria for SLE
4. Female subjects must use 1 effective method of avoiding pregnancy,…
Contacts